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# India OTC Drug Manufacturer Slapped With Form-483
- URL: https://www.fdaweb.com/india-otc-drug-manufacturer-slapped-with-form-483/
- Published: 2026-05-27T12:00:00.000Z
- Updated: 2026-09-14T13:40:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161210

FDA has cited Dabur India Limited for significant manufacturing and data integrity violations at an over-the-counter drug manufacturing facility in India, according to a just-posted inspection report that detailed falsified records, questionable microbiology testing practices and sanitation problems. FDA issued a [Form-483](https://www.fda.gov/media/192690/download?ref=fdaweb.com) following a 1/12-16 inspection of Dabur’s facility in Dadra and Nagar Haveli, India, where investigators documented seven observations tied to quality control, cleaning validation, documentation practices and contamination risks.

Among the most serious findings were allegations that laboratory microbiology data may have been manipulated. FDA investigators said reviews of microbiology testing records showed “100%” of certain finished product samples reported zero colony counts, despite inspectors observing microbial colonies — including some deemed “too numerous to count” — on plates during the inspection. The agency also cited repetitive numerical patterns in microbial testing data that “suggest the data may not reflect actual analytical test results.”

FDA said Dabur’s quality control unit failed to adequately oversee laboratory operations and did not investigate the absence of microbiological out-of-specification results over a five-year period. Investigators also reported missing microbiology plates and the absence of sample receipt logs needed to track testing timelines and chain of custody.

Inspectors further alleged that the company falsified manufacturing records. According to the Form 483, the company created new equipment usage documentation that removed references to several U.S.-marketed products in order to support claims that certain manufacturing lines were dedicated to specific products. FDA said original logbooks showed the equipment had in fact been used for multiple over-the-counter products.

The agency also identified major deficiencies in cleaning validation procedures for non-dedicated manufacturing equipment used across multiple products. Investigators said the company relied primarily on visual inspections rather than scientifically validated residue testing and lacked adequate controls to prevent cross-contamination.

Additional findings included discrepancies between analytical data and certificates of analysis, missing equipment logbook entries, incomplete batch manufacturing records and failures to conduct annual product quality reviews for numerous products.